- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01851070
A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor
A Double-blind, Randomized, Placebo-controlled, Dose-escalation, Multi-center Study a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Alabama
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Anniston, Alabama, 미국, 36207
- Pinnacle Research Group
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Arizona
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Gilbert, Arizona, 미국, 85234
- Arthrocare Arthritis Care and Research PC
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California
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El Cajon, California, 미국, 92020
- Triwest Research Associates
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Los Angeles, California, 미국, 90025
- UCLA
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Upland, California, 미국, 91786
- Inland Rheumatology Clinical Trials Incorporated
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Florida
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Ocala, Florida, 미국, 34474
- Ocala Rheumatology Research Center
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Palm Harbor, Florida, 미국, 34684
- Arthritis Center
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Sarasota, Florida, 미국, 34239
- Sarasota Arthritis Research Center
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Tampa, Florida, 미국, 33614
- McIlwain Medical Group
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Maryland
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Baltimore, Maryland, 미국, 21224
- JHU Arthritis Center Baltimore
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Frederick, Maryland, 미국, 21702
- Arthritis Treatment Center
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Massachusetts
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Worcester, Massachusetts, 미국, 01605
- Reliant Medical Group
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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New Jersey
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Fair Lawn, New Jersey, 미국, 07410
- Office of Ramesh C. Gupta, MD
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North Carolina
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Charlotte, North Carolina, 미국, 28210
- DJL Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73102
- Health Research of Oklahoma
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15261
- University of Pittsburgh
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Tennessee
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Jackson, Tennessee, 미국, 38305
- West Tennessee Research Institute
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Texas
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Houston, Texas, 미국, 77034
- Accurate Clinical Research
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San Antonio, Texas, 미국, 78217
- Texas Arthritis Research Center
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New South Wales
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Camperdown, New South Wales, 호주, 2050
- Royal Prince Alfred Hospital
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Tasmania
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Hobart, Tasmania, 호주, 7000
- Southern Clinical Research Pty Ltd
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Victoria
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Malvern, Victoria, 호주, 3145
- Emeritus Research
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Males and Females ages 18-80 years old
- Active rheumatoid arthritis (RA) disease as per 2010 ACR/EULAR classification criteria for the diagnosis of RA.
- Must be positive for rheumatoid factor and/or anti-cyclic citrullinated peptide (anti-CCP3) but without extra-articular disease or functional limitation
Patient with active RA defined as:
- ≥ 4 tender joint count (TJC) 28 joint count at screening and
- ≥ 4 swollen joint count (SJC) count 28 joint count at screening
- ESR ≥ 28 mm/hr or hsCRP >2.0 mg/L
- Patient has been taking MTX for at least 4 months with dose and route of administration stable for at least 8 weeks prior to screening
- Patient has had an inadequate response to at least one TNFα inhibitor with last dose at least 6 weeks prior to screening
- Use of oral DMARD (sulfasalazine, hydroxychloroquine, chloroquine and leflunomide) is permitted but must be stable for at least 3 months prior to screening
Exclusion Criteria:
- Pregnant women or women who are breastfeeding.
- Other investigational therapy received within 8 weeks or five half-lives (whichever is longer) prior to Screening (except as in exclusion #13).
- Known or suspected alcohol or drug abuse within three years preceding Screening.
- Autoimmune disease other than RA (such as systemic lupus erythematosus (SLE), mixed connective tissue disease, scleroderma, polymyositis/dermatomyositis, vasculitis)
- History of or current inflammatory joint disease other than RA (such as tophaceous gout, reactive arthritis, psoriatic arthritis, ankylosing spondylitis or other spondyloarthropathy, Lyme disease). Patients primarily diagnosed with osteoarthritis are excluded.
- Bedridden or confined to a wheelchair or patients with > 3 arthroplasties due to RA.
- History of diagnosed and/or treated malignancy with no evidence of recurrence in past 5 years
- Surgical procedures planned to occur during the trial (these patients may be rescreened following completion of and recovery from the surgical procedure).
- Use of TNFα inhibitor for treatment of RA at time of screening or within the 6 weeks prior to screening.
- Prior use of biologic agent for treatment of RA within 6 weeks prior to screening
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Normal Saline Placebo
Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.
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활성 비교기: Allogeneic Mesenchymal Precursor Cells
Mesenchymal Precursor Cells (MPCs), either 1.0 or 2.0 million cells/kg, will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-infusion
기간: 12 weeks post IV Infusion
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To evaluate the safety, tolerability and feasibility of a single intravenous (IV) infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who have received methotrexate +/- other oral DMARDs for at least 4 months and who have had an incomplete response to at least one course of a TNFα inhibitor. Overall safety will be based on the overall assessment of AE/SAEs, Vital Signs, Physical Examination, clinical laboratory tests, ECGs and Chest x-ray. |
12 weeks post IV Infusion
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Evaluation of the efficacy of a single intravenous infusion of allogeneic MPCs compared with placebo at 12 weeks post-infusion with MPCs or placebo in the treatment of patients with active RA
기간: 12 weeks post IV infusion with MPCs
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To assess the efficacy of a single intravenous infusion of allogeneic MPCs compared with placebo at 12 weeks post-infusion with MPCs or placebo in the treatment of patients with active RA who have received methotrexate +/- other DMARDs for at least 4 months and who have had an incomplete response to least one TNFα inhibitor.
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12 weeks post IV infusion with MPCs
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Evaluation of long-term safety and efficacy of a singly IV infusion of allogeneic MPCs in patients with active RA
기간: 52 weeks post IV Infusion
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To evaluate the long-term efficacy and safety of allogeneic MPCs over the entire study duration in the treatment of patients with active RA who have received methotrexate +/- other DMARDs for at least 4 months and who have had an incomplete response to at least one TNFα inhibitor Safety will be assessed according to the following:
Efficacy will be assessed according to the following:
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52 weeks post IV Infusion
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공동 작업자 및 조사자
스폰서
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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